Trial · NCT06444451
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
NCT06444451, Phase 2, Terminated, Sanofi
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata. Trials, record NCT06444451. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06444451
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
- NCT number
- NCT06444451
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 166 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Alopecia Areata
- Interventions
- Amlitelimab, Placebo
- First posted
- 2024-06-05
- Last updated
- 2026-08-10
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in Severity of Alopecia Tool (SALT) score at Week 36 | Baseline to Week 36 | SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). |
| Secondary | Change from the baseline in SALT score at Week 24 (key secondary) | Baseline to Week 24 | SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). |
| Secondary | Proportion of participants achieving a SALT score ≤20 at Weeks 24 and 36 | Week 24 and 36 | SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). |
| Secondary | Time to SALT score ≤20 | Up to Week 36 | SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). |
| Secondary | Proportion of participants achieving a SALT score ≤10 at Weeks 24 and 36 | Week 24 and 36 | SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). |
| Secondary | Time to SALT score ≤10 | Up to Week 36 | SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). |
| Secondary | Proportion of participants achieving a SALT50 at Weeks 24 and 36 | Week 24 and 36 | SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). SALT50 is 50% reduction from baseline in SALT score. |
| Secondary | Proportion of participants achieving a SALT75 at Weeks 24 and 36 | Week 24 and36 | SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). SALT75 is 75% reduction from baseline in SALT score. |
| Secondary | Proportion of participants achieving a SALT90 at Weeks 24 and 36 | Week 24 and 36 | SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). SALT90 is 90% reduction from baseline in SALT score. |
| Secondary | Proportion of participants achieving ClinRO Measure for eyebrow (EB) Hair Loss 0 or 1 with ≥2-point improvement from baseline at Weeks 24 and 36 (among participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline) | Week 24 and 36 | ClinRO Measure for EB Hair Loss is a single item, clinician-reported numeric rating scale (NRS) measuring eyebrow hair loss. Scores range from 0 = normal appearance/no eyebrow hair loss to 3 = severe appearance/severe eyebrow hair loss |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06444451
GET https://conductscience.org/api/trials/v1/NCT06444451/registered